Federal Expert Committee for Biosafety FECB Transport of infectious substances and genetically modified organisms Julia Link Federal Expert Committee for Biosafety www.efbs.admin.ch julia.link@bafu.admin.ch
Topics National and international transport regulations Definition / classification Packaging requirements Outlook 2
Legal Basis Gene Technology Law Law on the Protection of the Environment Ordinance on the Contained Use of Microorganisms: Art. 14 Transport 1 Anyone transporting genetically modified or pathogenic microorganisms must observe applicable, national and international transport regulations regarding labelling and packaging. 2 These transport regulations apply by analogy to the transport of genetically modified or pathogenic organisms, in particular genetically modified animals and plants, and plant-pathogenic microorganisms 3
International and National Transport- Regulations Mode of Transport International National UN Model Regulations Road ADR SDR Railway RID RSD Air ICAO / IATA LTrV Sea / Inland Waterways Post Dangerous Goods IMO /ADN LPM ADNR / BSV GGBV See BSO-Manual for abbreviations: http://www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en&download=nhzlpzig7t,lnp6i0ntu0 42l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCEeYR,fmym162dpYbUzd,Gpd6emK2Oz9aGodetmqaN19XI2IdvoaCVZ,s-.pdf 4
Definitions Infectious Substances (class 6.2, ADR 2.2.62): Substances which are known or are reasonably expected to contain pathogens Infectious substances, affecting humans (Category A) Infectious substances, affecting animals only (Category A) Biological products (Category B) Clinical waste (Category B) Genetically modified microorganisms and organisms (class 9, ADR 2.2.9): Genetically modified microorganisms (GMMOs) and genetically modified organisms (GMOs) are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. They are assigned to Class 9 (UN No. 3245) if they do not meet the definition of infectious substances, but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction. Plant pathogens Not subject to dangerous goods regulations, but subject to containment ordinance. Plant toxins have to be assigned to UN 3172 or UN 3462, respectively (class 6.1, ADR 2.2.61). 5
Flowchart for the classification of infectious substances Source: Guidance on regulations for the transport of infectious substances 2007-, WHO 6
Infectious substances: Exemptions Not considered as infectious substances (ADR 2.2.62.1.5): Substances unlikely to cause disease Microorganisms which are non-pathogenic to humans and animals Substances which have been neutralized or inactivated Infectious substances with concentrations at a natural level (food stuff, water, air and soil samples, living persons) Blood (components) for the use of transfusion or transplantation Biological products for purposes of final packaging or use for personal health care Human or animal specimens with minimal likelihood that pathogens are present: Exempt human (animal) specimen 7
Classification Infectious Substances (class 6.2, ADR 2.2.62): Substances which are known or are reasonably expected to contain pathogens Infectious substances, affecting humans (Category A) Infectious substances, affecting animals only (Category A) Biological products (Category B) Clinical waste (Category B) 8
Infectious Substances: Category A Category A substance (ADR, 2.2.62.1.4.1): An infectious substance ( ) which is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. List of category A substances (ADR, 2.2.62.1.4.1) The list of these substances (mainly bacteria and viruses of risk groups 3 and 4) is not exhaustive. Assignment to UN 2814 Infectious substance, affecting humans UN 2900 Infectious substance, affecting animals only 9
Category A substances: Examples 10
Infectious substances: Category B Category B substance (ADR 2.2.62.1.4.2): An infectious substance which does not meet the criteria for inclusion in Category A Assignment to UN 3373, Biological product, Category B UN 3291, Clinical waste Formerly named Diagnostic specimen or Clinical specimen Infectious substances assigned to UN No. 3373 which are packed and packages which are marked in accordance with this packing instruction are not subject to any other requirement in ADR (ADR 4.1.4.1, P650). 11
Infectious substances: Examples Material Risk Group Category Class UN number ADR Pack. Instr. Documentation Label Bacillus anthracis Culture 3 A 6.2 UN 2814 P 620 Dangerous goods transport documents Biohazard Bacillus anthracis Patient specimen 3 B 6.2. UN 3373 P 650 none UN 3373 diamond Influenza pandemic strain 2-4 A 6.2 UN 2814 P 620 Dangerous goods transport documents Biohazard Influenza vaccine none (a) none (a) none (a) none (a) none (a) Influenza vaccine research B 6.2. UN 3373 P 650 none UN 3373 diamond a) Vaccines are considered as biological products which do not fall under dangerous goods regulations 12
Genetically modified organisms GMOs (ADR 2.2.9.1.11) Genetically modified organisms not meeting the definition of an infectious substance, but which are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction. Assignment to UN 3245, genetically modified organisms Stricter transport requirements than for Category B substances! P904 is not suited for genetically modified animals and plants! 13
Packing provisions Packaging (ADR 4.1) UN 2814 / UN 2900: P 620 Category A UN 3373: P 650 Category B UN 3291: P 621 Clinical waste UN 3245: P 904 GMOs General Requirements Triple packaging Marking Specific requirements (except for UN 3373) Dangerous goods transport documents (ADR 5.4.1) Instruction in writing (ADR 5.4.3) Biohazard label 14
Example for P 620 (Category A) Further provisions / restrictions: Training of persons involved Security provisions Safety adviser Carrier No transport by Swiss Post! 15
Example for P 650 (Category B) Packaging are similar to P 620 P 620 does not need a UN certified packaging Differences with respect to stability, marking and labelling Biological Products Category B can be transported by Swiss Post! Leakproof primary receptacle Absorbent and padding material Leakproof secondary packaging Marking and Labelling Rigid outer packaging 16
Infectious substances: Examples Material Risk Group Category Class UN number ADR Pack. Instr. Documentation Label Bacillus anthracis Culture 3 A 6.2 UN 2814 P 620 Dangerous goods transport documents Biohazard Bacillus anthracis Patient specimen 3 B 6.2. UN 3373 P 650 none UN 3373 diamond Influenza pandemic strain 2-4 A 6.2 UN 2814 P 620 Dangerous goods transport documents Biohazard Influenza vaccine none (a) none (a) none (a) none (a) none (a) Influenza vaccine research B 6.2. UN 3373 P 650 none UN 3373 diamond a) Vaccines are considered as biological products which do not fall under dangerous goods regulations 17
Important Your responsibilities as consignor /sender (ADR 1.4): Correct classification Correct packaging Correct marking and labelling Documentation Further obligations: Export and import of biological material: Additional regulations must be complied with! See BSO-Manual or contact FOPH BSO-Manual: http://www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en&do wnload=nhzlpzig7t,lnp6i0ntu042l2z6ln1ad1izn4z2qzpno2yuq2z6gpjceeyr,f mym162dpybuzd,gpd6emk2oz9agodetmqan19xi2idvoacvz,s-.pdf 18